FDA 510(k) Microbiology Devices
FDA 510(k) Microbiology Devices - Regulatory Overview
FDA 510(k) microbiology devices include diagnostic systems used to detect and identify bacteria, viruses, fungi and parasites. The FDA review panel code is MI.
Key device types:
- Blood culture systems - automated incubation and detection platforms
- Microbial identification - MALDI-TOF, biochemical and molecular ID systems
- Antimicrobial susceptibility testing - MIC determination and breakpoint analysis
- Rapid infectious disease tests - influenza, strep, RSV, COVID-19 antigen and molecular tests
- Molecular diagnostics - PCR panels for respiratory, GI and STI pathogens
7067
Total
7005
Cleared
149d
Avg (2y)
1976
Since
5928 Microbiology devices
Cleared
Jul 28, 2008
PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G
LSE
Epstein-barr Virus, Other
238d
Cleared
Jul 24, 2008
ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML
JWY
Manual Antimicrobial Susceptibility Test Systems
73d
Cleared
Jul 17, 2008
ADVIA CENTAUR HAVM ASSAY
LOL
Hepatitis A Test (antibody And Igm Antibody)
29d
Cleared
Jul 10, 2008
ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT
MKZ
Dna Probe, Nucleic Acid Amplification, Chlamydia
115d
Cleared
Jun 26, 2008
PLATELIA LYME IGM
LSR
Reagent, Borrelia Serological Reagent
42d
Cleared
Jun 25, 2008
XTAG RESPIRATORY VIRAL PANEL
OCC
Respiratory Virus Panel Nucleic Acid Assay System
28d
Cleared
Jun 23, 2008
NUCLISENS EASYQ ENTEROVIRUS SYSTEM
OAI
Assay, Enterovirus Nucleic Acid
602d
Cleared
Jun 13, 2008
D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
LIN
Antisera, Conjugated Fluorescent, Cytomegalovirus
50d
Cleared
Jun 13, 2008
MRSASELECT - EXTENDED INCUBATION
JSO
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
45d
Cleared
Jun 11, 2008
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
LLH
Reagents, Clostridium Difficile Toxin
70d
Cleared
Jun 09, 2008
ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
LGD
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
179d
Cleared
May 30, 2008
ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM
MXJ
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
298d
Cleared
May 23, 2008
ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC
LGD
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
53d
Cleared
May 12, 2008
DORIPENEM 10UG BBL SENSI-DISC
JTN
Susceptibility Test Discs, Antimicrobial
35d
Cleared
May 08, 2008
PLATELIA LYME IGG ASSAY
LSR
Reagent, Borrelia Serological Reagent
126d
Cleared
Apr 30, 2008
VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
93d
Cleared
Apr 16, 2008
RAMP INFLUENZA A/B ASSAY
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
310d
Cleared
Mar 31, 2008
B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM
NTM
Antigen, Inflammatory Response Marker, Sepsis
424d
Cleared
Mar 20, 2008
SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE
JWY
Manual Antimicrobial Susceptibility Test Systems
85d
Cleared
Mar 13, 2008
SENSITITRE 18-24 SUSCEPTIBILITY PLATE
JWY
Manual Antimicrobial Susceptibility Test Systems
85d
Cleared
Mar 05, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
76d
Cleared
Feb 28, 2008
SPECTRA MRSA
JSO
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
125d
Cleared
Feb 28, 2008
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
44d
Cleared
Jan 29, 2008
HARDYDISK AST DORIPENEM 10 UG
JTN
Susceptibility Test Discs, Antimicrobial
26d
Cleared
Jan 23, 2008
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
50d
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